Community-based Education, Navigation, and Support Intervention for Military Veterans
CENS
Evaluation of a Community-based Education, Navigation, and Support (CENS) Intervention to Reduce Opioid-related Harms Among Military Veterans
1 other identifier
interventional
300
1 country
1
Brief Summary
Military veterans in the U.S. represent one of the populations most disproportionately impacted by the current opioid crisis. Veterans who use opioids and are not connected to the VA healthcare system have high rates of homelessness and experience higher prevalence of comorbid substance use disorder and mental health diagnoses than their "service-connected" counterparts. Due to these vulnerabilities and the observed barriers to testing and treatment among veterans-especially substance- and mental health-related stigma, drug naiveté, and limited support networks-veterans who use opioids represent a critical target for interventions designed to mitigate overdose and HIV/HCV risk behaviors. For socially isolated veterans and veterans with limited access to healthcare, programs that work outside of formal healthcare institutions and agencies are desperately needed. This application proposes to achieve the following Aims: 1) Evaluate the effectiveness of a peer-delivered, community-based education, navigation and support (CENS) intervention to reduce opioid-related risk behaviors; 2) Examine factors that mediate (e.g., knowledge, self-efficacy, self-stigma) and moderate (e.g., mental health, pain/OUD severity, age) intervention effectiveness; and 3) Explore intervention participants' and peer outreach staff perspectives on implementation as well as barriers to and facilitators of intervention effectiveness. The proposed intervention will be delivered by veteran peer outreach workers. The study will recruit 300 veterans with opioid use disorder to participate in a randomized controlled trial. The CENS intervention will engage 150 participants in ongoing educational sessions, healthcare and treatment navigation, and social support (involving both one-on-one and group social integration protocols) designed to improve self-efficacy, reduce self-stigma, increase service and healthcare utilization, and bolster knowledge. This study stands to contribute a timely, culturally-tailored innovation to overdose and HIV/HCV prevention-as-usual that, informed by the theory of triadic influence, directly confronts the social, intrapersonal, and structural-level barriers to opioid-related risk reduction among veterans. Study findings will be of great interest to community-based and civic healthcare organizations that provide overdose and HIV/HCV risk reduction outreach, as well as to agencies committed to improving healthcare engagement among veterans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2022
CompletedStudy Start
First participant enrolled
October 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
July 1, 2025
June 1, 2025
3.6 years
March 8, 2022
June 26, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Opioid Overdose Risk Behaviors Scale
Change in Overdose Risk Behavior Scale score, from baseline to 9 months. Min Score= 0 Max Score = 660 Higher scores indicate more engagement in overdose risk behaviors
9 months follow-up assesment
Change in HIV/HCV Risk Behaviors
Change in HIV/HCV risk behaviors as measured by the National HIV Behavioral Surveillance System questions about unsafe sexual and injection risk, from baseline to 9 month follow up.
9 months follow-up assessment
Secondary Outcomes (3)
Health service utilization
9 months follow-up assessment
Drug Treatment
9 months follow-up assessment
HIV/HCV Testing
9 months follow-up assessment
Study Arms (2)
CENS Intervention
EXPERIMENTALPeer outreach workers will deliver Overdose Education and Naloxone to participants and provide education, navigation, and support during the 9-month intervention
Control
OTHERParticipants will receive Overdose Education and Naloxone and referrals to treatment
Interventions
Education on OD risk behaviors and methods for responding to an OD, including naloxone use. Duration and dose: Single 20-minute training at time of enrollment, provided to all participants in both arms
Education about misinformation about OAT, self-care, SEP services, HIV/HCV treatment Duration/dose: 9 mos., monthly \~2 hr. group sessions + ongoing access to video archive of recorded trainings.
Help navigate access and barriers to healthcare, motivation and health goals Duration/dose: 9 mos., monthly face-to-face sessions to set goals and schedule appts, phone calls between sessions \> 1x/wk.
Support with social (re)integration, isolation, relationship building Duration/dose: 9 mos., monthly face-to-face events and phone calls/texts between sessions \> 1x/wk.
Eligibility Criteria
You may qualify if:
- Veteran status
- Adult (18+) age
- Current nonmedical use of opioids
- Current clinical (DSM-5) opioid use disorder of any level of severity
You may not qualify if:
- Unable to speak English
- Unable to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University
New York, New York, 10003, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander S Bennett, PhD
New York University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2022
First Posted
April 25, 2022
Study Start
October 21, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be shared one year after completion of study or by June 2027.
- Access Criteria
- (1) commitment to use data for research purposes only and not to identify individual study participants; (2) commitment to promote objectivity in research using these data by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH awards will be free from bias (3) commitment to use appropriate information technology systems to keep data secure; and (4) commitment to returning or destroying data after analyses are complete.
Data will be shared via openICPSR© Self-Deposit Package. All specific identifies will be removed from final datasets prior to release for sharing. To prevent the unlikely but possible deductive disclosure of participant identity with particular characteristics, the study team will make the data available to other investigators only after discussion and under a formal data-sharing agreement that provides for: (1) commitment to use data for research purposes only and not to identify individual study participants; (2) commitment to promote objectivity in research using these data by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH awards will be free from bias (3) commitment to use appropriate information technology systems to keep data secure; and (4) commitment to returning or destroying data after analyses are complete.